Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery.
NCT ID: NCT06461052
Last Updated: 2025-02-12
Study Results
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Basic Information
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COMPLETED
NA
198 participants
INTERVENTIONAL
2024-03-12
2024-07-05
Brief Summary
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Detailed Description
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* the need for more anesthetic agents to achieve the same level of depth of anesthesia in anxious patients compared to non-anxious/low-anxiety patients
* Development of chronic postoperative pain.
The preoperative consultation and visit by an anaesthetist is an important meeting point to reduce these high levels of anxiety. On the other hand, systematic benzodiazepine-based premedication has been abandoned for some years now, and taking action to reduce the level of anxiety is one of today's challenges, using a variety of means: organizational, video, music, virtual reality, hypnosis...
Unfortunately, the level of publication on the subject remains low.
Currently, a local analysis of this pathway shows several waiting times for which patients are not necessarily informed, and which can generate anxiety during treatment. In addition, our preliminary survey on the subject showed a specific need for information on pain management and anaesthesia recovery. and anesthesia recovery.
The goal of this study was to design a two-group comparative study aiming of significantly reducing perioperative anxiety in outpatients by implementing simple solutions. More specifically, our project focuses on the impact of music therapy and dedicated information via an explanatory video of the patient's journey through the operating room on the level of perioperative anxiety.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
No interventions assigned to this group
Intervention
patient information via a video explaining the procedure, followed by a15-minute music therapy session of your choice in the OR waiting room.
music therapy
The patient will benefit from viewing the video and the music therapy session in the waiting room of the operating room. The patient will be asked again for their anxiety score using an anxiety scale. This will define the main outcome of the study. Following this collection and in order not to influence the response, investigators will collect from the patient his compliance with the two proposed techniques as well as his appreciation of the tool.
Interventions
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music therapy
The patient will benefit from viewing the video and the music therapy session in the waiting room of the operating room. The patient will be asked again for their anxiety score using an anxiety scale. This will define the main outcome of the study. Following this collection and in order not to influence the response, investigators will collect from the patient his compliance with the two proposed techniques as well as his appreciation of the tool.
Eligibility Criteria
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Inclusion Criteria
* under general anesthesia. The surgeries surgeries concerned are versatile: Digestive (inguinal hernias, proctology, cholecystectomy, etc.), thoracic endoscopy (biopsy examination under GA), gynecological (hysteroscopy, diagnostic laparoscopy diagnostic laparoscopy, cerclage...), ENT (endoscopies, septoplasty, meatotomy...), Urology (JJ catheter insertionTOT/TVT, botulinum toxin injection...), vascular (stripping)
* Patient with oral non-opposition prior to any study procedure
* Not to have objected to inclusion in the research
* Patient affiliated to a health insurance scheme
Exclusion Criteria
* Patient not respecting the central block route (interventional radiology in this case)
* First patients in the program because they present the risk of less than than 15 minutes
* Patients who do not understand French
* Patient deprived of liberty or under guardianship
* Pregnant or breast-feeding women
18 Years
80 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Morgan LE GUEN, MD
Role: PRINCIPAL_INVESTIGATOR
FOCH Hospital
Locations
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DRCI FOCH Hospital
Suresnes, , France
FOCH Hospital
Suresnes, , France
Countries
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References
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Friedrich S, Reis S, Meybohm P, Kranke P. Preoperative anxiety. Curr Opin Anaesthesiol. 2022 Dec 1;35(6):674-678. doi: 10.1097/ACO.0000000000001186. Epub 2022 Sep 21.
Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.
Eijlers R, Dierckx B, Staals LM, Berghmans JM, van der Schroeff MP, Strabbing EM, Wijnen RMH, Hillegers MHJ, Legerstee JS, Utens EMWJ. Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):728-737. doi: 10.1097/EJA.0000000000001059.
Gurler H, Yilmaz M, Turk KE. Preoperative Anxiety Levels in Surgical Patients: A Comparison of Three Different Scale Scores. J Perianesth Nurs. 2022 Feb;37(1):69-74. doi: 10.1016/j.jopan.2021.05.013. Epub 2021 Nov 19.
Hedayati J, Bagheri-Nesami M, Elyasi F, Hosseinnataj A. The Effect of Music Therapy on the Pain and Anxiety Levels of Patients Experiencing Wound Healing by Suturing in the Emergency Wards. Anesth Pain Med. 2023 Feb 25;13(1):e132943. doi: 10.5812/aapm-132943. eCollection 2023 Feb.
Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.
Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.
Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.
Other Identifiers
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2023-A02493-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021_0188
Identifier Type: -
Identifier Source: org_study_id
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